A Randomized, Double-Blind, Single-Center, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, PK and PD of Intravenous DTRI-031 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- DTRI-031
- Conditions
- Healthy Volunteers
- Sponsor
- Basking Biosciences, Inc.
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Safety as assessed by adverse events (AEs)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
A randomized, double-blind, single center, placebo-controlled phase 1 study in healthy volunteers to assess safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single intravenous (iv) injection of DTRI-031
Detailed Description
Up to 5 cohorts of 8 healthy volunteers for a total of 40 volunteers will be randomized to either DTRI-031 or matching placebo (6 active:2 placebo). Two sentinel subjects, one randomized to each group, will be dosed at least 1 day prior to dosing of the remaining subjects in a cohort. Subjects will complete a screening visit up to 28 days prior to administration of study drug to confirm eligibility. Eligible subjects will arrive at the phase 1 unit up to 24 hours prior to Day 1 and remain until completion of 24-hour assessments. Subjects will return for a Day 7 follow-up visit and receive a safety assessment telephone call on Day 28. A Safety Review Committee will review individual subject and aggregate group safety data following each dose-based study cohort and recommend whether the trial should continue to the next cohort.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18-55 years of age
- •Ability to provide written consent
- •Weight 50-110 kg with BMI 18.5-32 kg/m2
- •Willingness to use contraceptives
- •Negative COVID-19 test
- •Negative results for alcohol and drugs of abuse
Exclusion Criteria
- •Pregnant or lactating females
- •Familial bleeding disorder or individual or family history of bleeding diathesis or coagulopathy
- •Females with active menstruation on day of dosing
- •Use of prescription medications known to affect platelet function
- •Use of NSAIDs, aspirin, anti-platelet or anti-coagulation therapy within 10 days of dosing
- •Contraindication to anticoagulation or increased bleeding risks
- •History of thrombocytosis, high platelet count, intracranial bleeding, aneurysm, stroke, vascular disease
- •History of peptic ulcer disease, gastrointestinal or genitourinary bleed, severe trauma, fracture, major surgery of biopsy of parenchymal organ within past 3 months
- •Planned surgery during the study
- •Any clinical significant abnormality at screening
Arms & Interventions
Active Comparator: Single ascending dose DTRI-031
Drug: DTRI-031 Single doses of DTRI-031 delivered via intravenous injection. Ascending dose levels will be evaluated.
Intervention: DTRI-031
Placebo Comparator: Single Dose Placebo
Drug: Placebo Single doses of placebo delivered via intravenous injection, matched to DTRI-031 cohorts
Intervention: Placebo
Outcomes
Primary Outcomes
Safety as assessed by adverse events (AEs)
Time Frame: From dosing (DTRI-031 or placebo) to final visit (Day 28)
Incidence of treatment-emergent AEs
Secondary Outcomes
- Platelet Function(From dosing to 24 hours after dosing)
- Plasma von Willebrand Factor (vWF) levels(From dosing to 24 hours after dosing)
- Pharmacokinetics as measured by DTRI-031 plasma levels(From dosing to 24 hours after dosing)